A Study of Prasugrel in Healthy Participants
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Prasugrel ODT1 - Tablet (Drug); Prasugrel ODT2 - Tablet (Drug); Prasugrel ODT2 - Suspension (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
The purpose of this study is to evaluate the amount of drug available in the body when given
to healthy participants as two different formulations with or without a meal. In addition,
this study will evaluate how much of the drug gets into the blood stream and how long the
body takes to get rid of it. Information about any side effects that may occur will also be
collected. Each participant will receive a total of five different treatments. Each
treatment is given by mouth, once a day. The treatment period lasts for five consecutive
days.
Clinical Details
Official title: Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference FormulationPharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation
Secondary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed StatePharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State
Detailed description:
The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and
the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Body mass index (BMI) of 18. 5 to 32. 0 kilograms per square meter (kg/m^2)
Exclusion Criteria:
- No known allergies to Prasugrel or related compound
- No regular alcohol intake greater than 21 units per week for males or 14 units per
week for females
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dallas, Texas, United States
Additional Information
Starting date: July 2012
Last updated: August 30, 2013
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